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Validation Engineer / CQV

Hired by Matrix

Round Lake, IL

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JOB DETAILS
SALARY
$63–$65 Per Hour
SKILLS
Autoclave, Biology, Biotech and Pharmaceutical, Change Control, Cleanroom, Commission Controls, Commissioning, Consulting, Corporate Compliance, Corrective and Preventative Action (CAPA) Systems, Document Management, Documentation, Drug Manufacturing, Environmental Monitoring, GMP (Good Manufacturing Practices), GxP, HVAC, Laboratory Equipment, Manufacturing, Manufacturing Equipment, Manufacturing Operations, Manufacturing Systems, Operational Support, Process Validation, Project Schedule, Regulations, Root Cause Analysis, Standard Operating Procedures (SOP), Startup, Support Documentation, Technical Recruiting, Technical Writing, Temperature Mapping, Testing, Time Management, Traceability, Validation Documentation, Validation Plan, Warehousing, Water For Injection (WFI), Writing Skills
LOCATION
Round Lake, IL
POSTED
30 days ago
At-a-Glance:
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a Validation Engineer / CQV.

Position Type:
  • Contract
  • On-Site 
Required:
  • Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related discipline.
  • 3 - 10 years of experience in CQV, Validation, or Pharmaceutical Manufacturing environments.
  • Hands-on experience with equipment qualification (IQ/OQ/PQ) in regulated GMP facilities.
  • Experience qualifying manufacturing equipment, autoclaves, washers, filling systems, and laboratory equipment.
  • Knowledge of temperature mapping and qualification methodologies.
  • Understanding of GxP regulations and validation lifecycle principles.
  • Experience reviewing and approving validation documentation and SOPs.
  • Strong technical writing and execution skills. 
Preferred:
  • Experience in both sterile and non-sterile pharmaceutical manufacturing environments.
  • Familiarity with Validation Master Plans (VMPs).
  • Process Validation experience.
  • Cleaning Validation experience.
  • Previous consulting or project-based validation experience preferred. 
Responsibilities:
  • Support commissioning, qualification, and validation activities for a new GMP facility and manufacturing areas.
  • Author, review, and execute validation deliverables including MVPs, Validation Plans, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.
  • Perform cleanroom qualification activities including airflow visualization, room recovery testing, differential pressure verification, and environmental monitoring support.
  • Execute qualification activities for autoclaves, parts washers, glassware washers, CTUs, process equipment, and associated utility systems.
  • Perform temperature mapping studies for refrigerators, freezers, incubators, stability chambers, warehouses, and other controlled temperature storage areas.
  • Support qualification of facility and utility systems including HVAC, WFI, clean steam, compressed gases, and other GMP utilities.
  • Investigate protocol deviations, discrepancies, and validation issues; support impact assessments, root cause investigations, and CAPA activities.
  • Review, revise, and author SOPs, work instructions, and other controlled GMP documentation to support startup and operational readiness.
  • Work closely with Engineering, Facilities, Quality, Manufacturing, and vendors to support project timelines and qualification activities.
  • Support change controls, commissioning turnover packages, punch list resolution, and validation lifecycle activities as required.
  • Ensure all qualification and validation activities are performed in accordance with GMP requirements, site procedures, and project schedules.
 
Key Responsibilities:
  • Review, execute, and provide technical sign-off on qualification documentation, including SOPs and validation protocols.
  • Support commissioning, qualification, and validation (CQV) activities for manufacturing and utility equipment.
  • Perform and document Performance Qualifications (PQs) for GMP manufacturing systems.
  • Execute qualification activities for:
    • Benchtop laboratory equipment
    • Autoclaves
    • Washers
    • Filling equipment
    • General manufacturing equipment
    • Temperature mapping studies
  • Support Validation Master Plan (VMP) execution and compliance activities.
  • Ensure all qualification and validation activities comply with GxP requirements and company procedures.
  • Collaborate with Quality, Manufacturing, Engineering, and Validation teams to meet project timelines.
  • Provide support for sterile and non-sterile manufacturing operations.
  • Contribute to process validation and cleaning validation activities as required.
Get in Touch:
We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Priyanshu at 201-478-6913 to learn more.

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About the Company

H

Hired by Matrix

We believe in putting people together for the right reasons. Getting you a great job that makes you feel fulfilled in your career. Finding the perfect candidate to help you achieve business success. Whether you are looking for the best candidate for your company or searching for your next career move, we are dedicated to making sure you thrive. We take your needs personally and have a variety of services to ensure you reach your goals. We listen to the needs of our clients and candidates and then thoughtfully match the right person with the right job. When people come together doing what they love success is guaranteed and partnerships last.
COMPANY SIZE
100 to 499 employees
INDUSTRY
Staffing/Employment Agencies
WEBSITE
http://www.hiredbymatrix.com